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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameEXABLATE 2100 SYSTEM
Classification Nameablation system, high intensity focused ultrasound (hifu), mr-guided
Generic Namemagnetic resonance guidedfocused ultrasound
ApplicantINSIGHTEC, INC.
PMA NumberP040003
Supplement NumberS007
Date Received01/22/2010
Decision Date04/19/2010
Product Code
NRZ[ Registered Establishments with NRZ ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study protocol.
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